Cytel Inc. seeks Senior Statistical Programmer in Waltham, MA to support our statistical programming to provide statistical input into Phase I - IV clinical trial development, perform the analysis of clinical trial data, and provide statistical input into the reporting of clinical trial results. Responsibilities include: provide statistical input into protocol and case report form (CRF) development in all therapeutic areas (e.g., trial design, sample size estimation, randomization, statistical methods for protocols, edit checks for clinical trial data); communicate with clients regarding study protocol or statistical analysis issues; and write detailed statistical analysis plans including specifications for analysis files, consistency checks, tables, and figures. Analyze clinical trial data producing accurate results representing the outcome of the trial, validate statistical output, accurately interpret and clearly communicate statistical results and concepts to non-statisticians. Provide input into statistical standard operating procedures (SOPs) and general standardization efforts (e.g., statistical methodology standards, standard data presentations) and participate in interactions with regulatory agencies. Up to 100% telecommuting permitted. Up to 25% travel required in the Waltham and Lexington, MA areas.
Minimum Requirements: Master's degree in biology, pharmaceutical sciences, computer science, statistics, or a directly related health science field, and two years of experience with SAS programming with clinical trial data. Employer will also accept Bachelor's degree in biology, pharmaceutical sciences, computer science, statistics, or a directly related health science field and five years of experience in SAS programming with clinical trial data Required experience must include 2 years’ experience (with a Master’s degree) or 5 years of experience (with a Bachelor’s degree) with each of the following: (1) providing statistical programming support for Phase II & III clinical trials; producing and validating analysis data sets, including metadata mapping specifications, consistent with CDISC (SDTM and ADaM) standards; (2) using SAS BASE, STAT, MACRO to develop TLFs, reports, ad hoc analysis based on SAP and other regulatory deliverables; (3) and collaborating with cross-functional teams, including statistician, clinical and data management. Interested candidates should send resume to email@example.com with job title and job code 13198 in subject line.